- Phase 3 clinical trial results for once-daily netarsudil ophthalmic solution
- Dexamethasone ophthalmic insert approved for new indication
- Results from home OCT feasibility study
- FDA accepts application for brolucizumab for DME
- Companies form alliance to develop nomograms, lens constants and astigmatism calculations
- AAO announces next CEO
- ASCRS news and events
October 15, 2021 • Volume 27, Number 41
Phase 3 clinical trial results for once-daily netarsudil ophthalmic solution
Aerie Pharmaceuticals released topline results from its Phase 3 clinical trial in Japan, which evaluated netarsudil ophthalmic solution, 0.02%, compared to ripasudil hydrochloride hydrate ophthalmic solution, 0.04%. According to the company, once-daily netarsudil was superior in lowering pressure at week 4 compared to the twice-daily ripasudil. A total of 245 participants were enrolled in the trial with a baseline diurnal IOP of 20.5 mm Hg in the netarsudil group and 20.8 mm Hg in the ripasudil group. After 4 weeks, IOP in the netarsudil group was reduced by 4.7 mm Hg (22.6%) compared to 3 mm Hg (14.3%) in the ripasudil group. Netarsudil is approved as Rhopressa in the U.S. and Rhokiinsa in the E.U.
Dexamethasone ophthalmic insert approved for new indication
Dextenza (dexamethasone ophthalmic insert, 0.4 mg, Ocular Therapeutix) was approved for an additional indication by the FDA. According to the company’s press release, the intracanalicular insert, also approved for ocular pain and inflammation following ophthalmic surgery, is now approved for ocular itching associated with allergic conjunctivitis. The single insert provides preservative-free dexamethasone as a therapy for up to 30 days. According to the company, three randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted to evaluate Dextenza’s effect on patients with a history of ocular allergy. All three trials showed lower itching scores in the group that received Dextenza compared to control.
Results from home OCT feasibility study
Notal Vision reported results from its first, U.S.-based feasibility study with its home OCT platform, Notal Home OCT. According to the company’s press release, the study evaluated the ability of patients with wet AMD to use the device for daily self-imaging for 3 months. The study found patients were able to use the device easily, it provided good image quality, compliant self-imaging, and spatio-temporal tracking of retinal fluid in a population of elderly patients with wet AMD. This research, according to the company, allows the technology to continue on its path toward FDA approval of the system, which in addition to the self-imaging device, includes the ability to transmit data via a built-in cellular modem to the Notal Health Cloud with remote viewing by investigators and image processing and quantification with the Notal OCT Analyzer deep learning algorithm.
FDA accepts application for brolucizumab for DME
Novartis announced that the FDA accepted its supplemental Biologics License Application for Beovu (brolucizumab, 6 mg) for treatment of DME. According to the company’s press release, the European Medicines Agency has also validated the type II variation application for Beovu, and the Japanese Pharmaceuticals and Medical Devices Agency accepted an application as well. The company reported that regulatory decisions are expected mid-2022 in the U.S. and Europe.
Companies form alliance to develop nomograms, lens constants and astigmatism calculations
Ziemer announced a strategic alliance with Zubisoft to create a new Digital Health Suite that will bring new nomograms and lens constant and astigmatism calculations to the market. According to the company’s press release, Zubisoft manufactures IBRA Digital Health Suite, a treatment planning and outcome system for cataract and refractive surgery. Under the agreement, Zubisoft will continue to sell and develop the system and Ziemer will get exclusive access to the technology as well as development support.
AAO announces next CEO
The American Academy of Ophthalmology (AAO) announced that Stephen McLeod, MD, will succeed David Parke II, MD, as CEO, effective February 1, 2022. Dr. Parke has served AAO as CEO for 12 years.
ASCRS news and events
- ASCRS Journal Club: The latest Journal Club, a series where a panel of experts discuss two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery (JCRS), is now available on demand.
- ASCRS Winter Symposium: Registration is open for the February 10–12, 2022, Winter Symposium in Park City, Utah. This meeting focuses on the innovative techniques and controversies in anterior segment ophthalmology and will also honor Alan Crandall, MD (1947–2020), former co-chair of this meeting, former ASCRS president, and a tireless teacher and humanitarian. Learn more.
- CME opportunity: “ASCRS Satellite CME: Supplemental Education to the ASCRS Annual Meeting” includes four, 1-hour programs captured from the 2021 Annual Meeting that are now available online and on-demand for viewing/claiming credit. Learn more.
- ASCRS Foundation: It’s National Sight Week! Visit the ASCRS Foundation’s website to see how volunteers are changing lives within their own communities by providing sight-restoring cataract surgery.
Research highlights
- A randomized clinical trial compared efficacy of patching to combined atropine and patching therapy (CAPT) in patients 3–12 years old with severe amblyopia resulting in strabismus. The study enrolled 108 patients, 53 of whom were randomized for CAPT and 55 for patching alone. The baseline mean visual acuity in the amblyopic eye was 0.95 logMAR (about 20/200 or 2.2 lines). After 6 months of therapy, the CAPT group improved to 0.75 logMAR (7.2 lines), and the patching group improved to 0.58 logMAR (5.8 lines). Visual acuity improvement was better maintained in the CAPT group than patching alone at 3 months. While there was more of an improvement with CAPT, the authors concluded that the clinical relevance cannot be determined due to the relatively small visual acuity difference between the two groups. The research is published in JAMA Ophthalmology.
- Survival rates of DMEK and DSAEK grafts in patients with prior glaucoma surgery (trabeculectomy or tubes) were evaluated in a retrospective, comparative case series published in the journal Cornea. Graft survival probability was 75% in both procedures (DMEK and DSAEK) at 1 year. It was 63% and 50% at year 2, 49% and 44% at year 3, 28% and 33% at year 4, and 28% and 19.5% at year 5 in the DMEK and DSAEK groups, respectively. Graft rejection rates overall were 20.8% in the DMEK group and 19.5% in the DSAEK group. There was not a significant difference in primary failure, rebubbling, endothelial cell loss, or IOP elevation, according to the authors. While preop BSCVA was not significantly different between the two groups, postop BSCVA was significantly better in the DMEK group at 6, 12, and 24 months. The authors reported that a multivariable model found the only significant factor affecting postop BSCVA was type of surgery, with DMEK being better.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor
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